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Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly (MED-RES-BONE)

23. mai 2026 oppdatert av: Antonella Muscella, University of Sfax

Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in Elderly

This randomized controlled trial was designed to investigate the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.

Participants underwent a detailed medical history assessment, clinical examination, and dietary evaluation. Individuals who met the inclusion criteria provided written informed consent prior to participation. All procedures were conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of Manouba University (no. C.S. ISSEP.KS N˚040/2024).

Eligible participants were randomly allocated to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the EXP group participated in supervised PRT sessions combined with a Mediterranean diet intervention, while the CON group received no structured intervention.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Detailed Description

This randomized controlled trial was conducted to examine the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.

Participants were recruited and screened through a detailed medical history assessment, clinical examination, and dietary evaluation. Eligible individuals who met the inclusion criteria provided written informed consent before participation.

Participants were randomly assigned to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the experimental group participated in supervised progressive resistance training sessions combined with a Mediterranean diet intervention, while the control group received no structured intervention and maintained their usual lifestyle.

Bone mineral density and bone turnover markers were assessed at baseline and after the 12-month intervention period.

Studietype

Intervensjonell

Registrering (Faktiske)

47

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Italia
    • LE
      • Lecce, LE, Italia, 73100
        • Antonella MUSCELLA

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adults aged 65 years and older
  • Ability to provide written informed consent
  • Willingness to comply with study procedures and interventions
  • Capability to participate in a supervised exercise program

Exclusion Criteria:

  • Presence of metabolic bone diseases (e.g., osteoporosis requiring pharmacological treatment, Paget's disease, osteomalacia)
  • Use of medications affecting bone metabolism, including systemic corticosteroids, bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, calcitonin, or parathyroid hormone analogs
  • Uncontrolled cardiometabolic or respiratory conditions (e.g., uncontrolled hypertension, unstable angina, recent cardiovascular events within 6 months, severe chronic obstructive pulmonary disease, or poorly controlled diabetes)
  • Severe musculoskeletal disorders or advanced osteoarthritis limiting safe exercise participation
  • Neurological or psychiatric conditions affecting mobility or adherence
  • Cognitive impairment (Mini-Mental State Examination score <24)
  • Recent fractures or major orthopedic surgery within the past 12 months
  • Underweight (BMI <18.5 kg/m²) or severe frailty
  • Severe renal or hepatic dysfunction (e.g., chronic kidney disease stage 4-5 or liver failure)
  • Active malignancy or ongoing chemotherapy/radiotherapy
  • Participation in another clinical trial within the previous 3 months

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Mediterranean Diet + Progressive Resistance Training
Participants followed a Mediterranean diet combined with a supervised progressive resistance training program performed three times per week for 12 months.
Atferdsmessig: Mediterranean Diet combined with Resistance Training
Participants followed a Mediterranean diet and engaged in a supervised progressive resistance training program performed three times per week for 12 months. The training was progressively adapted based on individual capacity, focusing on major muscle groups using standard resistance exercises.
Andre navn:
  • Mediterranean Diet and Supervised Resistance Training
Ingen inngripen: Control Group
No Structured Intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bone Mineral Density (BMD)
Tidsramme: Baseline and 12 months
Bone mineral density (BMD) was assessed using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and femoral neck. Measurements were performed at baseline and after the 12-month intervention period. esults will be reported as BMD values expressed in g/cm².
Baseline and 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bone Formation Markers
Tidsramme: Baseline and 12 months
Bone formation marker, osteocalcin were assessed in fasting blood samples. Unit of Measure: ng/mL
Baseline and 12 months
Bone Formation Markers
Tidsramme: Baseline and 12 months
Bone-specific alkaline phosphatase (BAP) were assessed in fasting blood samples. Unit of Measure: U/L
Baseline and 12 months
Bone Formation Markers
Tidsramme: Baseline and 12 months
Fasting serum P1NP concentrations will be assessed as a marker of bone formation. were assessed in fasting blood samples. Unit of Measure: ng/mL
Baseline and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sfax

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2024

Primær fullføring (Faktiske)

10. mars 2025

Studiet fullført (Faktiske)

10. mars 2025

Datoer for studieregistrering

Først innsendt

6. mai 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C.S. ISSEP.KS N˚040/2024

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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